Posts Tagged ‘FDA medical device classification’

When I was a kid in Chicago back in the 1960s there was a show on television called Bozo’s Circus. Lucky kids were picked from the audience to play a bucket game. There were six buckets in a row, as I remember, each about a foot from the last. The kids had to stand in front of the first bucket to play. By the time the kids got to throw their ball into Bucket No. 6 there was probably ten feet for the ball to travel. So what would happen if the ball didn’t sink into the desired bucket, which would happen more often than not it seemed? Then Ringmaster Ned would direct Cookie the Clown to chase down the rogue balls.

So what does this have to do with the FDA and medical devices? Well, in the loosest of terms you may think of the FDA’s classification system as Buckets 1 through 6 and Ringmaster Ned as the regulatory agent of the game. Okay, I’m really stretching on this analogy, but I did want to introduce some levity into the discussion!

Last week we discussed the fact that the FDA classifies medical devices into three main categories, Classes I, II and III, Class I devices posing the least risk to patients, Class III the most. Now we’ll see how the FDA regulatory control system functions to oversee the medical devices within each classification. To begin with, you should be aware that regulatory controls are themselves divided into General and Special Control categories. In this article we’ll focus on General Controls.

General Controls can apply to medical devices within all three FDA risk classifications. They include requirements for:

— Registering of medical device manufacturers, distributors, repackagers, and relabelers with the FDA. This registration basically lets the FDA know they exist as an entity, and it gives the Agency information about who to contact should the need arise.

— Listing medical devices with the FDA so the Agency can keep track of what kind of devices are being marketed in the United States.

— Manufacturing devices in accordance with FDA Good Manufacturing Practices (GMP). GMP regulations require a quality approach to manufacturing, an approach which is designed to minimize or eliminate instances of contamination, defect, and error which could contribute to harm or kill a patient. GMP regulations address issues like sanitation, quality control, complaint handling, and record keeping. Effective complaint handling and record keeping systems are key in identifying and resolving issues that may pose increased risk to patients.

— Labeling devices. The FDA requires that medical device labeling provide explicit directions for use. The labels must also contain appropriate warnings as needed to ensure the safe and effective use of the device.

— Submitting a Premarket Notification to the FDA for approval before marketing a device, also referred to as a 510(k) within the industry. This name comes from the section of the federal regulation that deals with it, that is to say, companies must submit 510(k) documents to the FDA to demonstrate that the device they wish to market is comparably safe and effective as other equivalent devices already on the market. A 510(k) can only be submitted if Premarket Approval (PMA) for the device is not required. We’ll talk more about this in a future article on Special Controls.

Now, because they pose such a low level of risk, many Class I medical devices are exempt from the requirement for 510(k) submissions altogether, and they may even be exempt from compliance with GMP regulations.

In a nutshell, General Controls help the FDA keep track of what products are being sold by whom, and how effective and safe those products are. It also provides guidelines to medical device companies to help ensure their introduction of safe and effective products to the public.

So what happens when a device falls outside of the parameters of the General Controls watch? That’s when more stringent guidelines come into play, for it has now entered the realm of Special Controls.

Hardly a week goes by that the FDA, that is the Food and Drug Administration, is not in the news. From the recall of drugs found to be harmful after the fact, to investigations of medical device suppliers and inspections of salmonella contamination at meat processing plants, the FDA is responsible for overseeing and regulating a wide range of products and processes. It’s stated purpose being:

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. http://www.fda.gov/AboutFDA/WhatWeDo/default.htm

From its humble beginnings at the beginning of the last century as the Pure Food and Drug Act, it has grown to regulate more than $1 trillion worth of consumer goods, about 25% of that said to be attributable to consumer goods expenditures in the United States. In 1976, the FDA began classifying medical devices, using a three-tiered system to distinguish them according to level of risk to patients. Class I devices present the lowest level of risk and requires the least regulatory control, while Classes II and III represent higher levels of risk.

Just to give you some perspective, Class I medical devices include things like tongue depressors, bedpans, arm slings, and hand-held surgical instruments. In the Class II category are things like surgical drapes, blood pressure cuffs, catheters, wheelchairs, heating pads, and x-ray film processing machines. And I’m sure you’ve guessed by now that Class III devices are for the heavy-hitters, including things like defibrillators, heart valves, and implanted cerebral stimulators.

So why does the FDA classify medical devices? Practicality is one key reason. It would be highly impractical, if not downright impossible, for the FDA to subject manufacturers of low risk Class I devices, like tongue depressors, to the same scrutiny as manufacturers of Class III devices, such as heart valves, etc. Along with miles of red tape would come a huge financial burden that would effectively raise the price of your common tongue depressor through the roof and, undoubtedly, force the manufacturer out of business.

Hand in hand with medical device classifications are regulatory controls imposed by the FDA. We’ll see how they fit into the picture next time.